Identity
- Trade Name
- X-RAY BACK SECTION FDA UDI
- Generic Name
- Universal operating table top FDA UDI
- Device Name
- 3/8" X-RAY BACK SECTION 3500/6500 FDA UDI
- Model / Reference
- 5-010-09-2B FDA UDI
- Description
- 3/8" X-RAY BACK SECTION 3500/6500 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10841736113001 FDA UDI
- FDA Product Code
- FQO FDA UDI
- GMDN Term
- Universal operating table top FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4960 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
X-Ray Back Section by Skytron, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Skytron, LLC
Sources (1)
- FDA UDI 22f3bf3e-0ea3-425d-8287-fa2da8f0b47b 35 fields · synced Jun 8, 2026